Is NCT03774446 recruiting in Los Angeles, CA?

Yes, NCT03774446 is currently recruiting participants at its Los Angeles, CA location. This cushing disease clinical trial is actively enrolling qualified participants.

How do I join the cushing disease clinical trial in Los Angeles?

To join this clinical trial in Los Angeles, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Los Angeles clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Cushing Disease Clinical Trial in Los Angeles, CA

Who Can Participate

Inclusion Criteria

Male and female patients at least 18 years old

Patients with confirmed pituitary origin of excess adrenocorticotropic hormone (ACTH) production:

Persistent hypercortisolemia established by two consecutive 24-hour UFC assessment ≥1.5× the upper limit of normal

Normal or elevated ACTH levels

Pituitary adenoma (\>1 cm) on MRI or inferior petrosal sinus sampling (IPSS) central to peripheral ACTH gradient \>2 at baseline and \>3 after CRH stimulation

Recurrent or persistent CD defined as pathologically confirmed resected pituitary ACTH-secreting tumor or IPSS central to peripheral ACTH gradient \>2 at baseline and \>3 after CRH stimulation, and 24h-UFC \>ULN beyond post-surgical week 6

Patients on medical treatment for Cushing disease. The following washout periods must be completed before screening assessments are performed:

Inhibitors of steroidogenesis: metyrapone, ketoconazole: 2 weeks; Levoketoconazole: 3 weeks; osilodrostat: 6 weeks

Somatostatin receptor ligand pasireotide: short-acting, 2 weeks; long-acting, 4 weeks

Progesterone receptor antagonist mifepristone: 2 weeks

Dopamine agonist cabergoline: 4 weeks

Patients treated with CYP3A or CYP2B6 strong inducers or inhibitors, including those listed below. Required washout time varies between drugs; minimum 5-6 times the half-life of the drug.

Strong CYP3A inducers: apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's wort

Moderate CYP3A inducers: bosentan, efavirenz, etravirine, phenobarbital, primidone

Weak CYP3A inducers: armodafinil, modafinil, rufinamide

Strong CYP2B6 inducer: carbamazepine

Moderate CYP2B6 inducers: efavirenz, rifampin

Weak CYP2B6 inducers: nevirapine, ritonavir

Strong CYP3A inhibitors: boceprevir, cobicistat, danoprevir and ritonavir, elvitegravir and ritonavir, grapefruit juice, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, paritaprevir and ritonavir and (ombitasvir and/or dasabuvir), posaconazole, ritonavir, saquinavir and ritonavir, telaprevir, tipranavir and ritonavir, telithromycin, troleandomycin, voriconazole, clarithromycin, idelalisib, nefazodone, nelfinavir.

Moderate CYP3A inhibitors: aprepitant, ciprofloxacin, conivaptan, crizotinib, cyclosporine, diltiazem, dronedarone, erythromycin, fluconazole, fluvoxamine, imatinib, verapamil

Strong CYP2B6 inhibitor: ticlopidine

Exclusion Criteria

Patients with compromised visual fields, and not stable for at least 6 months

Patients with abutment or compression of the optic chiasm on MRI and normal visual fields

Patients with Cushing's syndrome due to non-pituitary ACTH secretion

Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia

Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e., Carney Complex, McCune-Albright syndrome, Multiple endocrine neoplasia (MEN) 1

Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)

Patients with cyclic Cushing's syndrome defined by any measurement of UFC over the previous 1 months within normal range

Patients with pseudo-Cushing's syndrome, i.e., non-autonomous hypercortisolism due to overactivation of the hypothalamic-pituitary-adrenal (HPA) axis in uncontrolled depression, anxiety, obsessive compulsive disorder, morbid obesity, alcoholism, and uncontrolled diabetes mellitus

Patients who have undergone major surgery within 1 month prior to screening

Patients with serum K+\< 3.5 while on replacement treatment

Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C \>8%

Patients who have clinically significant impairment in cardiovascular function or are at risk thereof, as evidenced by congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, high grade atrioventricular (AV) block, history of acute MI less than one year prior to study entry

Patients with liver disease or history of liver disease such as cirrhosis, chronic active hepatitis B and C, or chronic persistent hepatitis, or patients with abnormal alanine transferase (ALT) or aspartate aminotransferase (AST) at screening or patients with advanced liver fibrosis (≥10 kPa) on elastography at screening

Patients with estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m2

Patients not biochemically euthyroid

Patients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation of its results, such as

History of immunocompromise, including a positive HIV test result (ELISA and Western blot). An HIV test will not be required, however, previous medical history will be reviewed

Presence of active or suspected acute or chronic uncontrolled infection

History of, or current alcohol misuse/abuse in the 12 month period prior to screening

Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. If a woman is participating in the trial then one form of contraception is sufficient (pill or diaphragm) and the partner should use a condom. If oral contraception is used in addition to condoms, the patient must have been practicing this method for at least two months prior to screening and must agree to continue the oral contraceptive throughout the course of the study and for 3 months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three months afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs)

Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to screening or patients who have previously been treated with seliciclib

Patients with any ongoing or likely to require additional concomitant medical treatment to treat CD

Patients who have received pituitary irradiation within the last 5 years prior to the baseline visit

Patients who have been treated with radionuclide at any time prior to study entry

Patients with known hypersensitivity to seliciclib

Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study

Patients with hepatitis B surface antigen (HbsAg) positivity

Patients with hepatitis C antibody (anti-HCV) positivity

Patients with prolonged QTcF on screening electrocardiogram (QTcF \>450 msec)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Los Angeles?

Yes, this clinical trial (NCT03774446) has an active research site in Los Angeles, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cushing Disease Treatment Options in Los Angeles, CA

If you're searching for cushing disease treatment options in Los Angeles, CA, this clinical trial (NCT03774446) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Los Angeles research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced cushing disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cushing disease clinical trials near you to find additional studies recruiting in your area.

Cushing Disease Clinical Trial in Los Angeles, CA

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About This Cushing Disease Study in Los Angeles